A World Leading Addiction Treatment Company with enormous future potential. JP Morgan Conference, San Francisco January 2016
|
|
- Annice Strickland
- 8 years ago
- Views:
Transcription
1 A World Leading Addiction Treatment Company with enormous future potential JP Morgan Conference, San Francisco January 2016
2 Forward Looking Statements This presentation contains certain statements that are forward-looking and which should be considered, amongst other statutory provisions, in light of the safe harbour provisions of the United States Private Securities Litigation Reform Act of By their nature, forward-looking statements involve risk and uncertainty as they relate to events or circumstances that will or may occur in the future. Actual results may differ materially from those expressed or implied in such statements because they relate to future events. Forward-looking statements include, among other things, statements regarding our financial guidance for 2015 and our medium- and long-term growth outlook, our operational goals, our product development pipeline and statements regarding ongoing litigation. Various factors may cause differences between Indivior's expectations and actual results, including: factors affecting sales of Suboxone Tablet, Suboxone Film, Subutex Tablet and any future products; the outcome of research and development activities; decisions by regulatory authorities regarding the Indivior Group s drug applications; the speed with which regulatory authorizations, pricing approvals and product launches may be achieved; the outcome of post-approval clinical trials; competitive developments; difficulties or delays in manufacturing; the impact of existing and future legislation and regulatory provisions on product exclusivity; trends toward managed care and healthcare cost containment; legislation or regulatory action affecting pharmaceutical product pricing, reimbursement or access; claims and concerns that may arise regarding the safety or efficacy of the Indivior Group s products and product candidates; risks related to legal proceedings; the Indivior Group s ability to protect its patents and other intellectual property; the outcome of the Suboxone Film patent litigation relating to the ongoing ANDA lawsuits; changes in governmental laws and regulations; issues related to the outsourcing of certain operational and staff functions to third parties; uncertainties related to general economic, political, business, industry, regulatory and market conditions; and the impact of acquisitions, divestitures, restructurings, internal reorganizations, product recalls and withdrawals and other unusual items. This presentation does not constitute an offer to sell, or the solicitation of an offer to subscribe for or otherwise acquire or dispose of shares in the Company to any person in any jurisdiction to whom it is unlawful to make such offer or solicitation. 2
3 Indivior PLC is the industry leader in treatment of addiction Global Leader in Opioid Addiction Treatment Structurally growing market Unrivalled experience and reputation Several Levers for Future Growth Pipeline & business development Global expansion Sustainable franchise with existing products Multi-layered IP protection to 2030 Strong, experienced, stable management team 3
4 OUR VISION That all patients around the world will have unrestricted access to high quality treatment services for the chronic relapsing conditions and co-morbidities of addiction
5 Four reasons to look at Indivior Addiction is a growing global epidemic 230m people worldwide abusing drugs, 153m dependent on opioids, cannabis, cocaine, other stimulants and alcohol Growing global governmental recognition of the issue Indivior is the main company working to expand access to treatment for addiction 5
6 Addiction A Growing Global Epidemic 230m people worldwide use illicit drugs 122m people worldwide dependent on alcohol (and under-reported) 23m people worldwide dependent on opioids (and under-reported) 8m people dependent on other substances cocaine, cannabis, methamphetamine 39 Deaths per 100,000 population due to alcohol and drug use implies >2.5m global deaths a year United Nations Office on Drugs and Crime, World Drug Report 2015 (United Nations publication, Sales No. E.15.XI.6); European Monitoring Centre for Drugs and Drug Addiction (EMCDDA): European Drug Report 2015: Trends and Development, doi: /084165; ISBN:
7 And the focus of growing attention Obama Administration Announces Public and Private Sector Efforts to Address Prescription Drug Abuse and Heroin Use White House : 21/10/2015 Obama Tells Outdated Opioid Treatment Industry It's Time To Change Huffington Post 21/10/2015 Panorama : Hooked on Painkillers Successful middle classes suffering crisis in alcohol abuse 24/7/2015 7
8 Certified physicians by year Cumulative Patients Treated But when authorities get it right, the market develops rapidly 2,500 The market has grown beyond expectations US market size by mg Supported by a consistent growth in certified physicians Nearly 6mm patients have received treatment through Suboxone therapy (tablets & film) 35,000 6,000,000 2,000 1,500 30,000 25,000 20,000 16,105 18,454 20,695 23,018 27,536 25,581 30,589 5,000,000 4,000,000 3,000,000 1, ,000 10,000 5,000 3,682 6,154 9,359 12,585 2,000,000 1,000, Source: Source Healthcare Analytics Retail and Non-Retail Sales data; Internal modeling October 2014 Source: NTIS DEA Certification List Source: Source Healthcare Analytics Retail Sales Data; internal modelling 8
9 Four reasons to look at Indivior Addiction is a growing global epidemic 230m people worldwide abusing drugs, 153m dependent on opioids, cannabis, cocaine, other stimulants and alcohol Growing global governmental recognition of the issue Indivior is the main company working to expand access to treatment for addiction A sustainable franchise with existing products in face of growing competition Suboxone Film is demonstrating resilience in US market with 59% share Valid & Enforceable patents extending up to
10 Generic bup/nal tablets launched Branded tablet launched CVS formulary loss United formulary loss and 3rd generic tablet approved Bunavail Launch Competition is intensifying, but Film share has been resilient 75% 70% 65% 60% 55% 50% 45% 40% 35% 30% 25% 20% 15% 10% 5% 0% 58.8% 19.7% 15.5% 5.2% 0.8% SUBOXONE FILM SUBOXONE TABLET GENERIC BUP GENERIC BUP/NAL ZUBSOLV BUNAVAIL
11 ANDA Litigation Update Trial in the lawsuits against Actavis and Par involving the Orange Book-listed patents for Suboxone Film November and December A decision in these lawsuits will follow post-trial briefing and is expected prior to any potential generic launch. Actavis 30 month stay of FDA approval expires February 28 th, Par s 30 month stay of FDA approval expires on September 25 th, Trial against Actavis and Par in the lawsuits involving the two recently granted process patents (US Patent No. 8,906,277 and US Patent No. 8,900,497) scheduled for November Trial against Teva in the lawsuit involving the Orange Booklisted patents and process patents for Suboxone Film scheduled for November 2016, with Teva s 30-month stay of FDA approval on ANDA No expiring April 17 th, Indivior believes Teva s 30-month stay of FDA approval on ANDA No also expires on April 17 th, 2017, however, Teva disputes the applicability of the stay to this ANDA. Trial against Alvogen in the lawsuit involving the Orange Book-listed patents and process patents for Suboxone Film scheduled for April 2017, with Alvogen s 30-month stay of FDA approval expiring October 28 th, Indivior received Paragraph IV notifications from Mylan and Sandoz on September 24 th, 2015 and October 2 nd, 2015, respectively. Indivior has filed patent infringement lawsuits against both ANDA-filers within 45-days of having received the Paragraph IV notifications, triggering the automatic stay of FDA approval of the ANDAs pursuant to the Hatch Waxman statute, with Mylan's stay expiring March 24th, 2018 and Sandoz's stay expiring April 2,
12 Four reasons to look at Indivior Addiction is a growing global epidemic 230m people worldwide abusing drugs, 153m dependent on opioids, cannabis, cocaine, other stimulants and alcohol Growing global governmental recognition of the issue Indivior is the main company working to expand access to treatment for addiction A sustainable franchise with existing products in face of growing competition Suboxone Film is demonstrating resilience in US market with 59% plus share Valid & Enforceable patents extending up to The world s leading pipeline to treat addiction Pipeline of innovative products to improve patient and physician outcomes Lifecycle management of Buprenorphine and extension into alcohol, cocaine and early stage developments on other addictions 12
13 AN INNOVATIVE PIPELINE DESIGNED TO IMPROVE PATIENT OUTCOMES Stages of development and earliest approval dates* Buprenorphine Lifecycle Suboxone Tablet Suboxone Film Buprenorphine Monthly Depot Oral Swallowable Capsule Overdose Rescue Products Cocaine Esterase Alcohol Use Disorders Arbaclofen Placarbil Adjacency - Schizophrenia Risperidone Monthly Depot Stage of Development Estimated Approval Dates Phase I Phase II Phase III NDA US US China Can? EU? China US US/EU EU * Dates are best estimates only and could be subject to change 13
14 Highlights of R&D delivery in 2015 Continuing progress with our innovative pipeline Label expansion for Suboxone Film (Buccal Indication) and new patents approved China FDA approved clinical trial application for Suboxone Film Nov 2015 French ATU for Nasal Naloxone approved Nov 2015 Compelling Phase 3 efficacy data (end points met) on Risperidone Monthly Depot, safety extension in progress Monthly buprenorphine depot progressing well through phase 3 1 new Phase 2 trial started (Arbaclofen Placarbil) 1 new Phase 1 trial initiated (RBP 6300) 6 peer reviewed publications plus two publications in press 14
15 PROGRESS ON PIPELINE IN 2015 Key Projects Product Stage Status RBP-6000: BUPRENORPHINE ONCE MONTHLY IN ATRIGEL RBP-6300: BUPRENORPHINE HEMIADIPATE IN ADF* Phase 3 (US) Phase 1 On track with pivotal efficacy trial (RB-US ): First patient randomized February 20 th, 2015 Current status On track with last patient in Nov Phase 3 Safety extension study (RB-US ) screening and enrollment ongoing. US Patent No.8,975,270 granted with expiry in 2031, the second Orange Book-listable patent upon FDA approval of NDA First Patient In pivotal PK study in Man (RB-EU ) Sept ARBACLOFEN PLACARBIL Phase 2A (US) * Abuse Deterrent Formulation Encap s Abusolve Pre-IND meeting with FDA January 29 th, 2015 IND submission June 26 th, 2015 First Patient screened In Phase IIA study (RB-US ) September
16 New Product Development: Psychiatric co-morbidities Product RBP-7000: Risperidone once monthly in Atrigel Status Phase 3 pivotal efficacy study (RB-US ): Completed; Preliminary data from pivotal Phase III Efficacy study were published on May 5th, 2015 Phase 3 long-term safety study (RB-US ): Enrolment ongoing Granted Patents: Orange Book-listable upon FDA approval of NDA 1) US Patent No. 9,190,197 (expiry 2028) 2) US Patent No. 9,186,413 (expiry 2028) Preliminary data from pivotal Phase III Efficacy study. Both doses met the primary endpoint with statistically and clinically significant reductions in the symptoms of acute schizophrenia over an 8-week treatment period using the change from baseline to end of treatment in the total Positive and Negative Syndrome Scale (PANSS) scores. RBP-7000 also met the key secondary endpoint with significant improvements in the Clinical Global Impression-Severity of Illness (CGI-S) scale compared with placebo over the 8-week treatment period. These results further emphasise the compatibility of our Atrigel drug delivery platform with a range of pharmaceutical compounds for their safe, sustained release over targeted time period through an easy biodegradable and biocompatible process. 16
17 Four reasons to look at Indivior Addiction is a growing global epidemic 230m people worldwide abusing drugs, 153m dependent on opioids, cannabis, cocaine, other stimulants and alcohol Growing global governmental recognition of the issue Indivior is the main company working to expand access to treatment for addiction A sustainable franchise with existing products in face of growing competition Suboxone Film is demonstrating resilience in US market with 59% plus share Valid & Enforceable patents extending up to The world s leading pipeline to treat addiction Pipeline of innovative products to improve patient and physician outcomes Lifecycle management of Buprenorphine and extension into alcohol, cocaine and early stage developments on other addictions A clear strategy and management with the experience and capabilities necessary to deliver the future 17
18 External routes to Growth Expand Global Treatment Access Expand treatment in USA = Grow the Market More physicians trained and waivered Increased awareness of treatment Reduced barriers to treatment access Opioid painkiller dependence in Europe 500K plus patient population unrecognised Growing awareness of condition Clinical trials for Suboxone in China Inorganic Growth Strategy Business Development in Addiction More than 70 compounds in addiction tracked Will bring assets in house at opportune time Adjacencies where our model works Focus on disease space where we add value Intensive market development Behavioural modification focus Sticking to our knitting Transformative M&A not on radar 18
19 Four reasons to look at Indivior Addiction is a growing global epidemic 230m people worldwide abusing drugs, 153m dependent on opioids, cannabis, cocaine, other stimulants and alcohol Growing global governmental recognition of the issue Indivior is the main company working to expand access to treatment for addiction A sustainable franchise with existing products in face of growing competition Suboxone Film is demonstrating resilience in US market with 59% plus share Valid & Enforceable patents extending up to The world s leading pipeline to treat addiction Pipeline of innovative products to improve patient and physician outcomes Lifecycle management of Buprenorphine and extension into alcohol, cocaine and early stage developments on other addictions A clear strategy and management with the experience and capabilities necessary to deliver the future 19
20 Financial Guidance for Indivior Guidance 2016 Indivior Guidance Net Revenue $m Operating Margin % >30% Net Income $m* *Excluding Exceptionals No material change in current market conditions; no deterioration in generic tablet pricing; limited impact of branded competition no generic film entry in modest loss of US share due to formulary changes & managed Medicaid accounts lost in 2015 Reinvestment of >$35m of the gross profit above original assumptions in driving innovations:- Buprenorphine Monthly Depot At constant exchange rates (to estimated 2015 averages) 20
21 Full Agenda for 2016 will be published on February 18th Date Activity Event Q1 Jan JP Morgan Conference Presenting Weds Jan 13 th Feb 18 FY 2015 Results Presentation in London Q2 May 3 Q1 Results Conference Call May 4-5 Deutsche Bank Conference Presentation (Boston) May 11 AGM London June 7-10 Jefferies Conference New York Presentation in New York H2 July 29 Half Year Results Presentation in London Sept 12 Morgan Stanley Conference Presentation in New York Nov 2 Q3 Results Conference Call 21
22 A World Leading Addiction Treatment Company with enormous future potential
A World Leading Addiction Treatment Company with enormous future potential. Jefferies Conference New York 2 nd June 2015
A World Leading Addiction Treatment Company with enormous future potential Jefferies Conference New York 2 nd June 2015 Shaun Thaxter Chief Executive Officer Forward-Looking Statements This presentation
More informationA World Leading Addiction Treatment Company with enormous future potential. Jefferies Healthcare Conference 2014
A World Leading Addiction Treatment Company with enormous future potential Jefferies Healthcare Conference 2014 Disclaimer. For the purposes of this disclaimer the "Presentation" shall mean and include
More informationENDEAVOR to take the first step towards changing their lives
Annual Report and Financial Statements 2014 By fully understanding the challenges that INDIVIDUAL patients face, we aim to transform addiction from a global human crisis to a recognized and treated disease
More informationCredit Suisse Healthcare Conference
Credit Suisse Healthcare Conference November 14, 2013 Safe Harbor Statement 2 Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: To the extent any statements made in this
More informationN a s d a q : I N S Y
N a s d a q : I N S Y Michael L. Babich, President and Chief Executive Officer Darryl S. Baker, Chief Financial Officer Jeffries Healthcare Conference, June 2014 Safe Harbor Statement This presentation
More informationDisclosure. This presentation contains forward-looking statements.
Disclosure This presentation contains forward-looking statements. These forward-looking statements are based on management's current expectations and assumptions as of the date of this presentation, and
More informationIN THE GENERAL ASSEMBLY STATE OF. Ensuring Access to Medication Assisted Treatment Act
IN THE GENERAL ASSEMBLY STATE OF Ensuring Access to Medication Assisted Treatment Act 1 Be it enacted by the People of the State of Assembly:, represented in the General 1 1 1 1 Section 1. Title. This
More informationOREXO AB SPECIALTY PHARMA FOCUSING ON OPIOID DEPENDENCE AND PAIN TREATMENT NORDIC LIFE SCIENCE CONFERENCE
OREXO AB SPECIALTY PHARMA FOCUSING ON OPIOID DEPENDENCE AND PAIN TREATMENT NORDIC LIFE SCIENCE CONFERENCE NASDAQ STOCKHOLM: ORX US OTC MARKET: ORXOY (ADR) APRIL 27 TH, 2015 LEGAL DISCLAIMER This presentation,
More informationPrior Authorization Guideline
Prior Authorization Guideline Guideline: CSD - Suboxone Therapeutic Class: Central Nervous System Agents Therapeutic Sub-Class: Analgesics and Antipyretics (Opiate Partial Agonists) Client: County of San
More information2015 OPSC Annual Convention. syllabus. February 4-8, 2015 Hyatt Regency Mission Bay San Diego, California
2015 OPSC Annual Convention syllabus February 4-8, 2015 Hyatt Regency Mission Bay San Diego, California FRIDAY, FEBRUARY 6, 2015: 9:30am - 10:30am Opioid Addiction and Buprenorphine Use * Presented by
More informationHow To Treat Anorexic Addiction With Medication Assisted Treatment
Medication Assisted Treatment for Opioid Addiction Tanya Hiser, MS, LPC Premier Care of Wisconsin, LLC October 21, 2015 How Did We Get Here? Civil War veterans and women 19th Century physicians cautious
More informationApplicant Webinar for BJA s Drug Court Discretionary Grant Solicitation
Applicant Webinar for BJA s Drug Court Discretionary Grant Solicitation Cynthia Caporizzo, Senior Criminal Justice Advisor, Office of National Drug Control Policy (ONDCP) - Review of the administration
More informationThe Determinations Report: A Report On the Physician Waiver Program Established by the. Drug Addiction Treatment Act of 2000 ( DATA )
The Determinations Report: A Report On the Physician Waiver Program Established by the Drug Addiction Treatment Act of 2000 ( DATA ) Submitted by the Center for Substance Abuse Treatment, Substance Abuse
More informationGovernor s Task Force on Mental Health and Substance Use. www.ncdhhs.gov/mhsu
Governor s Task Force on Mental Health and Substance Use www.ncdhhs.gov/mhsu Problem Statement 97 Painkiller prescriptions per 100 North Carolinians Number of deaths by drug overdose in North Carolina
More informationUsing Buprenorphine in an Opioid Treatment Program
Using Buprenorphine in an Opioid Treatment Program Thomas E. Freese, PhD Director of Training, UCLA Integrated Substance Abuse Programs Director, Pacific Southwest Addiction Technology Transfer Center
More informationInformation for Pharmacists
Page 43 by 42 CFR part 2. A general authorization for the release of medical or other information is NOT sufficient for this purpose. Information for Pharmacists SUBOXONE (buprenorphine HCl/naloxone HCl
More informationARCHIVED BULLETIN. Product No. 2004-L0424-013 SEPTEMBER 2004 U. S. D E P A R T M E N T O F J U S T I C E
BULLETIN INTELLIGENCE Product No. 2004-L0424-013 SEPTEMBER 2004 U. S. D E P A R T M E N T O F J U S T I C E NDIC Within the past 2 years buprenorphine a Schedule III drug has been made available for use
More informationThe Future of Consumer Health Care
The Future of Consumer Health Care Coming Together To Lead The Consumer Health Care Industry 2 Creating a New Business Model in Consumer Health Care 3 Serve More Consumers In More Parts of the World, More
More informationPain Therapeutics, Inc.
Pain Therapeutics, Inc. Pioneers in Preventing Prescription Drug Abuse Remi Barbier President & CEO June 2014 1 Forward-Looking Statements This presentation contains forward-looking statements within the
More informationDEVELOPING MANUFACTURING SUPPLYING. Naltrexone Implants. Manufactured by NalPharm Ltd WWW.NALPHARM.COM
DEVELOPING MANUFACTURING SUPPLYING Naltrexone Implants Background to Nalpharm NalPharm is a specialist pharmaceutical company supplying proprietary branded medications and generic drugs in the area of
More informationQ3 2015 Financial Results and Corporate Update. November 4, 2015
Q3 2015 Financial Results and Corporate Update November 4, 2015 Introductions and Forward- Looking Statements Silvia Taylor, SVP Investor Relations and Corporate Affairs Agenda Introductions and Forward-Looking
More informationHow To Grow A Company
Profitability & Growth in 2006: Corporate Overview April 2006 Certain statements in this presentation may constitute forward looking statements within the meaning of the Private Securities Litigation Reform
More informationTreatment of opioid use disorders
Treatment of opioid use disorders Gerardo Gonzalez, MD Associate Professor of Psychiatry Director, Division of Addiction Psychiatry Disclosures I have no financial conflicts to disclose I will review evidence
More informationOpiate Addiction in Ohio: An Update on Scope of Problem Ashland Ohio
Governor s Cabinet Opiate Action Team Promoting Wellness and Recovery John R. Kasich, Governor Tracy J. Plouck, Director Opiate Addiction in Ohio: An Update on Scope of Problem Ashland Ohio November 14,
More informationNeurobiology and Treatment of Opioid Dependence. Nebraska MAT Training September 29, 2011
Neurobiology and Treatment of Opioid Dependence Nebraska MAT Training September 29, 2011 Top 5 primary illegal drugs for persons age 18 29 entering treatment, % 30 25 20 15 10 Heroin or Prescription Opioids
More informationFlamel Technologies Provides Update on Corporate Progress
Flamel Technologies Provides Update on Corporate Progress Clinical Programs Continue to Move Forward Outlines Full Year 2016 Revenue Guidance Lyon, France January 8, 2016 - Flamel Technologies (NASDAQ:
More informationTRANSITION TO A COMMERCIAL AND PROFITABLE PHARMACEUTICAL COMPANY CONTINUES. Presenting at Småbolagsdagen June 10, 2013
TRANSITION TO A COMMERCIAL AND PROFITABLE PHARMACEUTICAL COMPANY CONTINUES Presenting at Småbolagsdagen June 10, 2013 LEGAL DISCLAIMER This presentation, which is personal to the recipient, has been prepared
More informationMedications for Alcohol and Drug Dependence Treatment
Medications for Alcohol and Drug Dependence Treatment Robert P. Schwartz, M.D. Medical Director Rschwartz@friendsresearch.org Friends Research Institute Medications for Alcohol Dependence Treatment Disulfiram
More informationA Review of the Impacts of Opiate Use in Ontario: Summary Report
A Review of the Impacts of Opiate Use in Ontario: Summary Report A Provincial Summary Report of the Impacts of the Discontinuation of Oxycontin in Ontario: January to August 2013 December 2013 This report
More informationIntegrating Medication- Assisted Treatment (MAT) for Opioid Use Disorders into Behavioral and Physical Healthcare Settings
Integrating Medication- Assisted Treatment (MAT) for Opioid Use Disorders into Behavioral and Physical Healthcare Settings All-Ohio Conference 3/27/2015 Christina M. Delos Reyes, MD Medical Consultant,
More informationMEDICAL POLICY Treatment of Opioid Dependence
POLICY........ PG-0313 EFFECTIVE......11/11/14 LAST REVIEW... 07/14/15 MEDICAL POLICY Treatment of Opioid Dependence GUIDELINES This policy does not certify benefits or authorization of benefits, which
More informationFrequently Asked Questions (FAQ s): Medication-Assisted Treatment for Opiate Addiction
Frequently Asked Questions (FAQ s): Medication-Assisted Treatment for Opiate Addiction March 3, 2008 By: David Rinaldo, Ph.D., Managing Partner, The Avisa Group In this FAQ What medications are currently
More informationMedication-Assisted Treatment for Opiate Addiction and the Public Financing of that Treatment
Medication-Assisted Treatment for Opiate Addiction and the Public Financing of that Treatment Introduction March 3, 2008 By: Suzanne Gelber, MSW, Ph.D., Managing Partner, The Avisa Group Defining Characteristics
More informationCare Management Council submission date: August 2013. Contact Information
Clinical Practice Approval Form Clinical Practice Title: Acute use of Buprenorphine for the Treatment of Opioid Dependence and Detoxification Type of Review: New Clinical Practice Revisions of Existing
More informationJohn R. Kasich, Governor Orman Hall, Director
John R. Kasich, Governor Orman Hall, Director 2 3 Epidemics of unintentional drug overdoses in Ohio, 1979-2011 1,2,3 1800 1600 1400 1200 1000 800 Prescription drugs are causing a larger overdose epidemic
More information5317 Cherry Lawn Rd, Huntington, WV 25705 Phone: (304) 302-2078 Fax: (304) 302-0279. Welcome
5317 Cherry Lawn Rd, Huntington, WV 25705 Phone: (304) 302-2078 Fax: (304) 302-0279 Welcome Welcome to Starlight Behavioral Health Opiate Dependence program. At Starlight, we believe that addiction is
More informationEllerston Global Investments Limited (ASX: EGI) encloses its quarterly investment report for June 2015.
SYDNEY NSW 2000 20 July 2015 Company Announcements Office ASX Limited Level 4, Exchange Centre 20 Bridge St SYDNEY NSW 2000 QUARTERLY INVESTMENT REPORT. (ASX: EGI) encloses its quarterly investment report
More informationInvestor science conference call: American College of Cardiology 2015
Investor science conference call: American College of Cardiology 2015 San Diego, California, USA 16 March 2015 Cautionary statement regarding forward-looking statements In order, among other things, to
More informationFORM 6-K. SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549. Report of Foreign Private Issuer
FORM 6-K SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 under the Securities Exchange Act of 1934 For the month of August 2011
More informationDeath in the Suburbs: How Prescription Painkillers and Heroin Have Changed Treatment and Recovery
Death in the Suburbs: How Prescription Painkillers and Heroin Have Changed Treatment and Recovery Marvin D. Seppala, MD Chief Medical Officer Hazelden Betty Ford Foundation This product is supported by
More informationThe Heroin and Prescription Drug Abuse Prevention and Reduction Act Section by Section
The Heroin and Prescription Drug Abuse Prevention and Reduction Act Section by Section TITLE I: PREVENTION SUBTITLE A- PRESCRIBER EDUCATION PRACTITIONER EDUCATION This subtitle requires practitioners who
More informationAntares Pharma, Inc. Princeton South Corporate Center 100 Princeton South, Suite 300 Ewing, NJ 08628 NASDAQ : ATRS. Paul
Antares Pharma, Inc. Princeton South Corporate Center 100 Princeton South, Suite 300 Ewing, NJ 08628 NASDAQ : ATRS Paul Antares Mission: To develop and commercialize self-administered parenteral medicines
More informationTreatment Approaches for Drug Addiction
Treatment Approaches for Drug Addiction [NOTE: This is a fact sheet covering research findings on effective treatment approaches for drug abuse and addiction. If you are seeking treatment, please call
More informationDisclosure. C.R. Sullivan, MD 1. Carl R. Sullivan, M.D. Professor and Director Addictions Program csullivan@hsc.wvu.edu. The West Virginia Model
West Virginia University School of Medicine BEHAVIORAL MEDICINE & PSYCHIATRY Morgantown, WV Carl R. Sullivan, M.D. Professor and Director Addictions Program csullivan@hsc.wvu.edu Disclosure Reckitt Benckiser
More informationPutting Addiction Treatment Medications to Use: Lessons Learned
Putting Addiction Treatment Medications to Use: Lessons Learned George E. Woody, M.D. Laura McNicholas, M.D., Ph.D. Department of Psychiatry, University of Pennsylvania School of Medicine and Philadelphia
More informationSUBOXONE /VIVITROL WEBINAR. Educational Training tool concerning the Non-Methadone Medication Assisted Treatment Policy that is Effective on 1/1/12
SUBOXONE /VIVITROL WEBINAR Educational Training tool concerning the Non-Methadone Medication Assisted Treatment Policy that is Effective on 1/1/12 WEBINAR INTRODUCTIONS Cynthia Parsons- Program Manager
More informationTufts Health Care Institute Program on Opioid Risk Management Pharmacotherapy for Prescription Opioid Addiction: Implications for Pain Management
Tufts Health Care Institute Program on Opioid Risk Management Pharmacotherapy for Prescription Opioid Addiction: Implications for Pain Management June 10 and 11, 2011 Executive Summary Introduction Opioid
More informationMEDICATION ASSISTED TREATMENT FOR OPIOID ADDICTION
MEDICATION ASSISTED TREATMENT FOR OPIOID ADDICTION Sidarth Wakhlu,M.D. Addiction Team Leader North Texas VA Health Care System Addiction Psychiatry Fellowship Director Associate Professor Of Psychiatry
More informationThe Federation of State Medical Boards 2013 Model Guidelines for Opioid Addiction Treatment in the Medical Office
The Federation of State Medical Boards 2013 Model Guidelines for Opioid Addiction Treatment in the Medical Office Adopted April 2013 for Consideration by State Medical Boards 2002 FSMB Model Guidelines
More informationMedication-Assisted Treatment for Opioid Addiction
Medication-Assisted Treatment for Opioid Addiction This document contains a general discussion of medications approved by the U.S. Food and Drug Administration (FDA) for use in the treatment of opioid
More informationOpioid overdose can occur when a patient misunderstands the directions
Facts About Opioid Overdose How Does an Overdose Occur? Opioid overdose can occur when a patient misunderstands the directions for use, accidentally takes an extra dose, or deliberately misuses a prescription
More informationTestimony on Opioid Overdose Prevention. Daniel Raymond, Policy Director, Harm Reduction Coalition
Testimony on Opioid Overdose Prevention Daniel Raymond, Policy Director, Harm Reduction Coalition Presented on March 25, 2014 to the House Appropriations Subcommittee on Labor, Health and Human Services,
More informationAppendices to Interim Report on the Baltimore Buprenorphine Initiative. Managed Care Organization Information Pages
Appendices to Interim Report on the Baltimore Buprenorphine Initiative Appendix A Managed Care Organization Information Pages Appendix B Buprenorphine Online Physician Training Information Packet Appendix
More informationTreatment Approaches for Drug Addiction
Treatment Approaches for Drug Addiction NOTE: This is a fact sheet covering research findings on effective treatment approaches for drug abuse and addiction. If you are seeking treatment, please call 1-800-662-HELP(4357)
More informationTestimony on Addressing Heroin and Opioid Addiction. Theodore Dallas. Secretary, Department of Human Services. Center for Rural Pennsylvania
Testimony on Addressing Heroin and Opioid Addiction Theodore Dallas Secretary, Department of Human Services Center for Rural Pennsylvania July 29, 2015 1 P a g e Introduction Good morning Senator Yaw,
More informationCorporate Presentation May 13, 2015
Corporate Presentation May 13, 2015 Creating the Next Generation of CNS Drugs Forward-Looking Statement This presentation contains forward-looking statements. These statements relate to future events and
More informationJennifer Sharpe Potter, PhD, MPH Associate Professor Division of Alcohol and Drug Addiction Department of Psychiatry
Buprenorphine/Naloxone and Methadone Maintenance Treatment Outcomes for Opioid Analgesic, Heroin, and Combined Users: Findings From Starting Treatment With Agonist Replacement Therapies (START) Jennifer
More informationTrends of Opioid Misuse and Diversion: Lessons from the United States
Trends of Opioid Misuse and Diversion: Lessons from the United States 31 October 2012 Richard C. Dart, MD, PhD Director Rocky Mountain Poison and Drug Center Professor - University of Colorado, Department
More informationDeveloping Medications to Treat Addiction: Implications for Policy and Practice. Nora D. Volkow, M.D. Director National Institute on Drug Abuse
Developing Medications to Treat Addiction: Implications for Policy and Practice Nora D. Volkow, M.D. Director National Institute on Drug Abuse Medications Currently Available For Nicotine Addiction Nicotine
More informationMEDICAID DRUG SPENDING ON ANTI- ADDICTION MEDICATION AND OPIOID ADDICTION REFRESHER
MEDICAID DRUG SPENDING ON ANTI- ADDICTION MEDICATION AND OPIOID ADDICTION REFRESHER TWO PRIMARY ACCESS POINTS Pharmacy Benefit Dispensed by a Pharmacy Billed via the PBM Process (NCPCP) Oversight by Drug
More informationU.S. House of Representatives Committee on Energy and Commerce Subcommittee on Health
TESTIMONY of the American Medical Association before the U.S. House of Representatives Committee on Energy and Commerce Subcommittee on Health Re: Examining Legislative Proposals to Combat our Nation's
More informationSubstance Use: Addressing Addiction and Emerging Issues
MODULE 6: SUBSTANCE USE: ADDRESSING ADDICTION AND EMERGING ISSUES Substance Use: Addressing Addiction and Emerging Issues Martha C. Romney, RN, MS, JD, MPH Assistant Professor Jefferson School of Population
More informationTRANSMUCOSAL IMMEDIATE RELEASE FENTANYL (TIRF) RISK EVALUATION AND MITIGATION STRATEGY (REMS)
Initial REMS approval: 12/2011 Most recent modification: /2014 TRANSMUCOSAL IMMEDIATE RELEASE FENTANYL (TIRF) RISK EVALUATION AND MITIGATION STRATEGY (REMS) Page 1 of 16 I. GOALS The goals of the TIRF
More informationMinimum Insurance Benefits for Patients with Opioid Use Disorder The Opioid Use Disorder Epidemic: The Evidence for Opioid Treatment:
Minimum Insurance Benefits for Patients with Opioid Use Disorder By David Kan, MD and Tauheed Zaman, MD Adopted by the California Society of Addiction Medicine Committee on Opioids and the California Society
More informationMatthew Emmens CEO Shire plc
Goldman Sachs 28 th Annual Global Healthcare Conference June 13, 2007 Matthew Emmens CEO Shire plc THE SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995 Statements included
More informationP U B L I C H E A L T H A D V I S O R Y
The Commonwealth of Massachusetts Executive Office of Health and Human Services Department of Public Health 250 Washington Street, Boston, MA 02108-4619Tel: 617-624-6000 Fax: 617-624-5206 www.mass.gov/dph
More informationStrong States, Strong Nation POLICY OPTIONS TO DECREASE RISKS FROM THE USE OF METHADONE AS A PAIN RELIEVER
Strong States, Strong Nation POLICY OPTIONS TO DECREASE RISKS FROM THE USE OF METHADONE AS A PAIN RELIEVER November 17, 2015 Today s Speakers Karmen Hanson, Program Manager, NCSL Cynthia Reilly, Director,
More informationopiates alcohol 27 opiates and alcohol 30 April 2016 drug addiction signs 42 Ranked #1 123 Drug Rehab Centers in New Jersey 100 Top 10 380
opiates alcohol 27 opiates and alcohol 30 April 2016 drug addiction signs 42 ed #1 123 Drug Rehab Centers in New Jersey 100 Top 10 380 effects of alcohol in the brain 100 Top 30 698 heroin addiction 100
More informationSAMHSA Initiatives to Educate Prescribers and Consumers and Treatment Resources
SAMHSA Initiatives to Educate Prescribers and Consumers and Treatment Resources Nick Reuter Division of Pharmacologic Therapy Substance Abuse and Mental Health Services Administration 1 Overview National
More informationNASDAQ: ATRS. Bank of America Merrill Lynch 2015 Health Care Conference May 13, 2015
NASDAQ: ATRS Bank of America Merrill Lynch 2015 Health Care Conference May 13, 2015 Safe Harbor Statement This presentation may contain forward-looking statements which are made pursuant to the safe harbor
More informationMagee-Womens Hospital
Magee-Womens Hospital Magee Pregnancy Recovery Program: History Pregnancy Recovery Center A Medical Home Model Approach to Strengthen Families Bawn Maguire, MSN, RN Programmatic Nurse Specialist Stephanie
More informationTitle: Opening Plenary Session Challenges and Opportunities to Impact the Opioid Dependence Crisis
The American Association for the Treatment of Opioid Dependence, provider #1044, is approved as a provider for social work continuing education by the Association of Social Work Boards (ASWB) www.aswb.org,
More informationFederal Response to Opioid Abuse Epidemic
Healthcare Committee Federal Response to Opioid Abuse Epidemic On May 1, 20215 the Energy and Commerce Subcommittee on Oversight and Investigations held a hearing entitled What is the Federal Government
More informationFederal Regulations For Prescribing Scheduled Controlled Substances
Federal Regulations For Prescribing Scheduled Controlled Substances HEIT TEMPLATE.PPT 1 Central Principle of Balance With the Use of Controlled Substances Dual imperative of government Establish a system
More informationPrescription Drug Abuse: Recognition, Intervention, and Prevention
Prescription Drug Abuse: Recognition, Intervention, and Prevention Nicholas Reuter Division of Pharmacologic Therapy Center for Substance Abuse Treatment Substance Abuse and Mental Health Services Administration
More informationFor a Healthier America: Reducing Prescription Drug Misuse and Abuse
For a Healthier America: Reducing Prescription Drug Misuse and Abuse The misuse and abuse of prescription medicines is a growing public health problem. In addition to the tragic toll on families and communities,
More informationMEDICAL ASSISTANCE BULLETIN
ISSUE DATE SUBJECT EFFECTIVE DATE MEDICAL ASSISTANCE BULLETIN NUMBER *See below BY Prior Authorization of Opiate Dependence Treatments Pharmacy Service Leesa M. Allen, Deputy Secretary Office of Medical
More informationOrange County Heroin Task Force Recommendations
Orange County Heroin Task Force Recommendations Law Enforcement Subcommittee 1) Continue Joint Enforcement Details with the Orange County Sheriff s Office, the Orlando Police Department and state and federal
More informationOpioid Addiction Treatment. Thomas R. Kosten, MD Professor of Psychiatry Baylor College of Medicine
Opioid Addiction Treatment Thomas R. Kosten, MD Professor of Psychiatry Baylor College of Medicine 1 Continuity of Care: A Critical Goal Is shorter cheaper? Re-hospitalization in 296 dependent patients
More informationEXPLORING NALOXONE UPTAKE AND USE PUBLIC MEETING July 01 02, 2015 Fred Wells Brason II fbrason@projectlazarus.org
EXPLORING NALOXONE UPTAKE AND USE PUBLIC MEETING July 01 02, 2015 Fred Wells Brason II fbrason@projectlazarus.org Disclosures Project Lazarus Zogenix Charitable Contribution 2015 Kaléo Charitable Contribution
More informationA LEADING GLOBAL HEALTHCARE COMPANY
A LEADING GLOBAL HEALTHCARE COMPANY Roadshow Boston March 2, 2016 Frankfurt stock exchange (DAX30): FRE US ADR program (OTC): FSNUY www.fresenius.com/investors SAFE HARBOR STATEMENT This presentation contains
More informationNon medical use of prescription medicines existing WHO advice
Non medical use of prescription medicines existing WHO advice Nicolas Clark Management of Substance Abuse Team WHO, Geneva Vienna, June 2010 clarkn@who.int Medical and Pharmaceutical role Recommendations
More informationTreatment of Opioid Dependence with Buprenorphine/Naloxone (Suboxone )
Treatment of Opioid Dependence with Buprenorphine/Naloxone (Suboxone ) Elinore F. McCance-Katz, M.D., Ph.D. Professor and Chair, Addiction Psychiatry Virginia Commonwealth University Neurobiology of Opiate
More informationTestimony of The New York City Department of Health and Mental Hygiene. before the
Testimony of The New York City Department of Health and Mental Hygiene before the New York City State Assembly Committee on Alcoholism and Drug Abuse on Programs and Services for the Treatment of Opioid
More informationOffice-based Treatment of Opioid Dependence with Buprenorphine
Office-based Treatment of Opioid Dependence with Buprenorphine David A. Fiellin, M.D Professor of Medicine, Investigative Medicine and Public Health Yale University School of Medicine Dr. Fiellin s Disclosures
More informationA LEADING GLOBAL HEALTH CARE GROUP. Frankfurt Stock Exchange (DAX30): FRE US ADR program (OTC): FSNUY wwww.fresenius.com/investors
A LEADING GLOBAL HEALTH CARE GROUP Frankfurt Stock Exchange (DAX30): FRE US ADR program (OTC): FSNUY wwww.fresenius.com/investors SAFE HARBOR STATEMENT This presentation contains forward-looking statements
More informationExpanding access to treatment for opiate addiction: Successes and Barriers
Expanding access to treatment for opiate addiction: Successes and Barriers Miriam Komaromy, MD Medical Director, Turquoise Lodge Addiction Treatment Hospital, NM Department of Health; and UNM Project ECHO
More informationGuidelines for the Use of Controlled Substances in the Treatment of Pain Adopted by the New Hampshire Medical Society, July 1998
Guidelines for the Use of Controlled Substances in the Treatment of Pain Adopted by the New Hampshire Medical Society, July 1998 Section I: Preamble The New Hampshire Medical Society believes that principles
More informationWeb-Based Resources. Locating Treatment
Web-Based Resources Locating Treatment http://dpt2.samhsa.gov/treatment/ -- This is the Substance Abuse and Mental Health Services Administration s (SAMHSA) page for locating both public and private opiate
More informationTestimony. For Members of the. House Health & Aging Subcommittee on Opiate Addiction Treatment and Reform. Janet Shaw, MBA, Executive Director
Testimony For Members of the House Health & Aging Subcommittee on Opiate Addiction Treatment and Reform Janet Shaw, MBA, Executive Director On behalf of the Ohio Psychiatric Physicians Association Interested
More informationPaul K. Wotton, Ph.D President and Chief Executive Officer May 2012 AMEX: AIS
Paul K. Wotton, Ph.D President and Chief Executive Officer May 2012 AMEX: AIS Safe Harbor Statement This presentation may contain forward-looking statements which are made pursuant to the safe harbor provisions
More informationPrior Authorization of buprenophine/naloxone (Suboxone ) or buprenorphine (Subutex )
June 2010 April 2009 Prior Authorization of buprenophine/naloxone (Suboxone ) or buprenorphine (Subutex ) Effective August 1, West Virginia Medicaid will require prior authorization for all Suboxone and
More informationTREATMENT MODALITIES. May, 2013
TREATMENT MODALITIES May, 2013 Treatment Modalities New York State Office of Alcoholism and Substance Abuse Services (NYS OASAS) regulates the addiction treatment modalities offered in New York State.
More informationTreatment of Prescription Opioid Dependence
Treatment of Prescription Opioid Dependence Roger D. Weiss, MD Chief, Division of Alcohol and Drug Abuse McLean Hospital, Belmont, MA Professor of Psychiatry, Harvard Medical School, Boston, MA Prescription
More informationOhio Legislative Service Commission
Ohio Legislative Service Commission Bill Analysis Brian D. Malachowsky H.B. 378 130th General Assembly () Reps. Smith and Sprague BILL SUMMARY Prohibits a physician from prescribing or personally furnishing
More informationUpdate and Review of Medication Assisted Treatments
Update and Review of Medication Assisted Treatments for Opiate and Alcohol Use Disorders Richard N. Whitney, MD Medical Director Addiction Services Shepherd Hill Newark, Ohio Medication Assisted Treatment
More informationANCILLARY STABILIZATION AND WITHDRAWAL. The Why And How Of Stabilizing The Patient In A Comprehensive Treatment Setting
ANCILLARY STABILIZATION AND WITHDRAWAL The Why And How Of Stabilizing The Patient In A Comprehensive Treatment Setting About CASAColumbia A science-based, multidisciplinary organization Focused on transforming
More informationFor personal use only
ACRUX (ACR) - ASX ANNOUNCEMENT 20 FEBRUARY 2014 ACRUX PROVIDES HALF YEAR UPDATE 2013 Highlights: Axiron sales milestone achieved US$25 million receivable early March 2014 Half-year financials: o Revenue
More informationXENOPORT INC FORM 8-K. (Current report filing) Filed 05/08/14 for the Period Ending 05/08/14
XENOPORT INC FORM 8-K (Current report filing) Filed 05/08/14 for the Period Ending 05/08/14 Address 3410 CENTRAL EXPRESSWAY SANTA CLARA, CA 95051 Telephone 4086167200 CIK 0001130591 Symbol XNPT SIC Code
More informationDeveloping Innovative Therapeutics for People with Orphan Liver Disease
Developing Innovative Therapeutics for People with Orphan Liver Disease PIPELINE PROGRESS AND FIRST QUARTER 2015 EARNINGS UPDATE NASDAQ: OCRX Forward-Looking Statements Certain statements in this presentation
More information